The gonadotrophin is chorionic

General characteristics. Structure:

Active ingredient: 500 ME, 1000 ME or 1500 ME gonadotrophins chorionic.

Excipients: Mannitolum (mannitol).

Pharmacological properties:

Pharmacodynamics. The gonadotrophin chorionic human (HGCh) - gonadotropic hormone which is produced by a placenta during pregnancy then in not changed look is removed by kidneys. For receiving drug it is extracted from urine and cleared. It is necessary for the normal growth and maturing of gametes at women and men, and also for production of sex hormones.

Has gonadotropic effect, follicle-stimulating and luteinizing. Luteinizing activity prevails over follicle-stimulating. Stimulates development of generative organs and secondary sexual characteristics. Drug causes an ovulation in women and stimulates synthesis of estrogen (oestradiol) and progesterone. At men - stimulates a spermatogenesis, products of testosterone and dihydrotestosterone.

Pharmacokinetics. After intramuscular introduction it is well soaked up. The elimination half-life makes 8 h. The maximum concentration of HGCh in a blood plasma is reached in 4-12 hours. The elimination half-life of a gonadotrophin chorionic makes 29-30 h, in case of daily intramuscular injections drug cumulation can be observed. The gonadotrophin chorionic is removed by kidneys. About 10-20% of the entered dose are found in urine in not changed look, the main part is removed in the form of β-chain fragments.

Indications to use:

At women:

- dysfunction of ovaries (anovulatory), amenorrhea;

- maintenance of a phase of a yellow body;

At men and boys:

- hypogonadotropic hypogonadism;

- the puberty delay caused by insufficiency of gonadotropic function of a hypophysis;

- the cryptorchism which is not caused by anatomic obstruction;

- insufficiency of a spermatogenesis, oligo-asthenospermia, azoospermism;

- when conducting differential diagnostic test of an anorchism and cryptorchism at boys;

- when carrying out the functional test of Leydiga for assessment of function of testicles at a hypogonadotropic hypogonadism before the long-term stimulating treatment.

Route of administration and doses:

After addition of solvent to lyophilisate the recovered solution of a gonadotrophin chorionic is entered intramusculary, slowly. The prepared solution is not subject to storage as further preservation of sterility of solution is not guaranteed. The specified dosages are approximate, treatment has to be adjusted by the doctor individually depending on necessary reaction to administration of drug.

At women:

- at anovulatory cycles the gonadotrophin chorionic is appointed since 10-12 in the afternoon by a menstrual cycle on 3000 ME 2-3 times with an interval of 2-3 days or on 1500 ME 6-7 times every other day;

- for maintenance of a phase of a yellow body everyone can be made from two to three repeated injections of drug in a dose from 1500 ME to 5000 ME within 9 days after an ovulation or transfer of an embryo (for example, for the 3, 6 and 9 day after induction of an ovulation).

At men and boys:

- at a hypogonadotropic hypogonadism - 1000-2000 ME drug 2-3 times a week. In case of infertility the combination of a gonadotrophin chorionic with the additional drug containing follitropin (follicle-stimulating hormone), 2-3 times a week is possible. The course of treatment has to proceed not less than 3 months when it is possible to expect any improvement of a spermatogenesis. During this treatment it is necessary to suspend replacement therapy by testosterone. When improvement of a spermatogenesis is reached, for its maintenance it is enough in certain cases the isolated use of a gonadotrophin chorionic;

- at the delay of puberty caused by insufficiency of gonadotropic function of a hypophysis - 1500 ME 2-3 times a week. A course of treatment - not less than 6 months;

- at the cryptorchism which is not caused by anatomic obstruction: aged from 3 up to 6 years - 500-1000 ME twice a week within 6 weeks; 6 years - 1500 ME twice a week within 6 weeks are aged more senior. The course of treatment can be in case of need repeated;

- at insufficiency of a spermatogenesis, oligoastenospermiya, azoospermism appoint 500 ME in combination with menotropiny (75 ME follicle-stimulating hormones + 75 ME luteinizing hormones) daily, or 2000 ME each 5 days in combination with menotropiny (150 ME follicle-stimulating hormones + 150 ME luteinizing hormones) 3 times a week within 3 months. In the absence of reaction to treatment appoint 2000 ME 2-3 times a week with menotropiny (150 ME follicle-stimulating hormones +150 ME of luteinizing hormone) 3 times a week within 3-12 months. At achievement of improvement of a spermatogenesis the subsequent therapy in some cases can be performed only by maintenance doses of a gonadotrophin chorionic;

- for the purpose of differential diagnosis of a cryptorchism and an anorchism at boys the Gonadotrophin chorionic is entered intramusculary once in a dosage of 100 ME/kg, concentration of testosterone in blood serum is defined prior to the beginning of the test and by 72-96 h after a drug injection. In case of an anorchism the test will be negative that testifies to lack of testicular fabric, in case of a cryptorchism even if there is only one small egg, positive (5-10-fold increase in concentration of testosterone). If the test slabopolozhitelny, is necessary search of a gonad (ultrasound examination of an abdominal cavity or a laparoscopy) as there is a high risk of a malignancy.

Features of use:

Pregnancy and lactation. Drug Gonadotrophin use chorionic during pregnancy and breastfeeding is contraindicated.

Use of a gonadotrophin increases risk of development of a venous or arterial thromboembolism therefore the patients getting into risk group need to estimate advantages of therapy of extracorporal fertilization. Also it should be noted that pregnancy in itself is also followed by the increased risk of thrombosis.

The probability of emergence of polycarpous pregnancy increases. During treatment by drug and within 10 days after the treatment termination the drug Gonadotrophin chorionic can exert impact on values of immunoassays on concentration of HGCh in a blood plasma and urine that can result in false positive test result on pregnancy.

Treatment of male patients by means of a gonadotrophin chorionic leads to increase in products of androgens therefore the patients getting into risk group have to be under strict medical control as the exacerbation of a disease or a recurrence can sometimes be result of the raised products of androgens.

HGCh promotes premature closing of an epiphysis or premature puberty. It is necessary to control a skeletogeny regularly.

At men drug is inefficient at the high content of follicle-stimulating hormone.

Unreasonably prolonged use of drug at a cryptorchism, especially if is shown an operative measure, can lead to a degeneration of gonads.

Long introduction can lead to antibody formation to drug.

Influence on ability to manage vehicles and mechanisms. During treatment it is necessary to abstain from driving of motor transport and occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

Disturbances from immune system: in rare instances there can be generalized rash or fever.

The general frustration and disturbances in an injection site: at use of a gonadotrophin chorionic there can be reactions in the place of an injection, for example, bruise, pain, reddening, a swelling and an itch. It was in certain cases reported about allergic reactions from most of which part was shown in the form of pain and/or rash in the place of an injection; increased fatigue.

At women.

Disturbances from a metabolism and food: hypostases.

Disturbances of mentality: irritability, uneasiness, depression.

Disturbances from a nervous system: headache, dizziness.

At men and boys.

Disturbances from endocrine system: premature puberty.

Disturbances from skin and hypodermic fabrics: eels.

Disturbances from generative organs and chest gland: treatment by a gonadotrophin chorionic sporadic can cause a gynecomastia; a prostate hyperplasia, increase in a penis, hypersensitivity of nipples of chest glands at men, increase in testicles in the inguinal channel at a cryptorchism.

If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor.

Interaction with other medicines:

It is necessary to avoid combined use of the drug Gonadotrophin chorionic with high doses of glucocorticosteroids.

Other interactions with medicines are noted.

Contraindications:

- hypersensitivity to HGCh or to any component of drug;

- hormonedependent malignant tumors of generative organs and a mammary gland now or suspicion on them (ovary cancer, a breast cancer, uterus cancer at women and a prostate cancer, a carcinoma of chest gland at men);

- organic lesions of the central nervous system (CNS) (tumor of a hypophysis, hypothalamus);

- thrombophlebitis of deep veins;

- hypothyroidism;

- adrenal insufficiency;

- giperprolaktinemiya;

- children's age up to 3 years;

At boys (in addition):
- premature puberty;

At men (in addition):

- the infertility which is not connected with a hypogonadotropic hypogonadism;

At women (in addition):

- wrong formation of generative organs incompatible with pregnancy;

- fibrous tumor of a uterus incompatible with pregnancy;

- primary insufficiency of ovaries;

- the infertility which is not connected with anovulation (for example, pipe or cervical genesis);

- bleeding or bloody allocations from a vagina of not clear etiology;

- pregnancy and period of breastfeeding.

With care. The persons having risk factors of thrombosis (the personal or family anamnesis, heavy obesity (a body weight index> of 30 kg/sq.m) or a thrombophilia).

At men and boys: with latent or explicit heart failure, a renal failure, arterial hypertension, epilepsy or migraine (or in the presence of these states in the anamnesis); at boys at prepubertal age; at patients with bronchial asthma.

If at you one of the listed diseases, before administration of drug surely consult with the doctor.

Overdose:

The gonadotrophin chorionic is characterized extremely by a hypotoxicity.

Women against the background of overdose can have a syndrome of hyper stimulation of ovaries (SHSO).

Depending on severity (on the basis of clinical laboratory symptoms) allocate several SGYa types:

 

Weight	Symptoms
SGYa of easy degree	Abdominal discomfort. Abdominal pains of insignificant intensity. Size of ovaries, as a rule, <8 см*.
SGYa of average degree	Morbidity of mammary glands. Abdominal pains of average intensity. Nausea and/or vomiting. Diarrhea. Ultrasonic symptoms of ascites. Small or average increase in cysts of ovaries. Size of ovaries, as a rule, 8-12 см*.
SGYa of heavy degree	Increase in body weight. In rare instances of a thromboembolism. Clinical signs of ascites (sometimes hydrothorax). Oliguria. Haemo concentration, hematocrit> 45%. Hypoproteinemia. Big cysts of ovaries (inclined to a gap). Size of ovaries, as a rule,> 12 см*.

* The size of ovaries can not correlate with severity of SGYa in cycles of the auxiliary reproductive technologies (ART) in connection with carrying out a puncture of follicles.

Principles of treatment of SGYa. Easy degree: bed rest; plentiful drink of mineral water; observation of a condition of the patient.

Average and heavy degrees (only in the conditions of a hospital):

- control of function of cardiovascular system (CCC), respiratory system, liver, kidneys, electrolytic and water balance (diuresis, dynamics of weight, change of a circle of a stomach);

- control of level of a hematocrit;

- crystalloid solutions intravenously kapelno (for recovery and maintenance of the volume of the circulating blood (VCB));

- colloidal solutions intravenously kapelno - 1,5-3 l/days (at haemo concentration preservation) and a resistant oliguria;

- a hemodialysis (at development of a renal failure);

- corticosteroid, antiprostaglandinovy, antihistaminic drugs (for decrease in permeability of capillaries);

- at a thromboembolism - low-molecular heparins (фраксипарин, клексан); a plasma exchange - 1-4 sessions with an interval of 1-2 days (improvement of rheological properties of blood, normalization of the acid-base state (ABS) and gas composition of blood, reduction of the sizes of ovaries);

- a paracentesis and a transvaginal puncture of an abdominal cavity at ascites. Hospitalization in a hospital is necessary at development SLEEPING average and heavy degree.

At men and boys development of a gynecomastia is possible; at boys the changes of behavior similar observed during the first phase of puberty are possible; a degeneration of gonads (at unreasonably prolonged use at a cryptorchism), an atrophy of seed tubules (owing to braking of products of follicle-stimulating hormone (FSG) as a result of stimulation of products of androgens and estrogen); reduction of quantity of spermatozoa in an ejaculate (at abuse of drug at men).

Prolonged use of drug can lead to strengthening of side effects.

Storage conditions:

In the place protected from light, at a temperature not above 20 °C. To store in the places unavailable to children. A period of validity - 4 years. Not to use after a period of validity.

Issue conditions:

According to the recipe

Packaging:

Lyophilisate for preparation of solution for intramuscular introduction, 500 ME, 1000 ME and 1500 ME. Packaging: in bottles from a tube glass. 5 bottles with drug in a blister strip packaging from a film polyvinyl chloride complete with 5 ampoules on 1 ml of solvent (sodium chloride, solution for injections of 9 mg/ml) in a blister strip packaging from a film polyvinyl chloride together with application instructions of drug and solvent, the scarificator or a knife ampoule in a pack from a cardboard. When packaging ampoules with notches, rings and points of a break scarificators or knives ampoule do not put.